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U.S. Department of Health and Human Services

Class 2 Device Recall Cobalt HF Quad MRI SureScan

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  Class 2 Device Recall Cobalt HF Quad MRI SureScan see related information
Date Initiated by Firm April 07, 2021
Create Date May 20, 2021
Recall Status1 Open3, Classified
Recall Number Z-1650-2021
Recall Event ID 87769
PMA Number P010031S674 
Product Classification Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D) - Product Code NIK
Product Cobalt HF Quad MRI SureScan Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D) - Product Usage: are multiprogrammable cardiac devices that monitor and regulate a patient s heart rate by providing single- or dual chamber rate responsive bradycardia pacing, cardioversion, and defibrillation therapies.
Code Information Product Number: DTPB2D4, UDI: 00763000178215  Serial Numbers: RTO601595S and RTO601624S
Recalling Firm/
Manufacturer		 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
8200 Coral Sea St Ne
Mounds View MN 55112-4391
For Additional Information Contact Technical Services
800-638-1991
Manufacturer Reason
for Recall		 The device may contain a manufacturing defect of a missing resistance spot weld (RSW).
FDA Determined
Cause 2		 Process control
Action During the week of 07-Apr-2021, Medtronic initiated retrieval activities for 1 device (1 US/0 OUS) for a consignee in possession of a potentially affected, non-implanted device according to Medtronic records. The Consignee was verbally notified that the consigned units was retrieved from consigned inventory and returned to Medtronic for engineering evaluation. The representative was made aware that a formal notification to customer regarding these immediate actions would follow once the engineering evaluations were complete. In the United States, beginning 20-Apr-2021, a formal Urgent Medical Device Recall notification was delivered via a field sales representative, to the consignee who was part of the retrieval activities initiated the week of 07-Apr-2021. This letter will also be mailed via UPS 2-day delivery. The Consignee will be asked to confirm receipt of the letter and that they have acknowledge the actions taken for the non-implanted, affected product.
Quantity in Commerce 2 units
Distribution US Nationwide distribution in the state of North Carolina.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
PMA Database PMAs with Product Code = NIK and Original Applicant = MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT
PMAs with Product Code = NIK and Original Applicant = Medtronic, Inc.
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